For patients
Clinical study means research on voluntary participants (test subjects) to improve their medical care and for the purpose of further developing medical knowledge. A distinction is made between non-interventional and interventional studies.
In a non-interventional study, no targeted “intervention” takes place. It is limited to observation and documentation.
Interventional (drug) studies are therapy studies in which a specific new treatment method is tested.
For doctors
ISA cooperates with other medical colleagues who are open to clinical studies.
This gives your patients access to new medicines that, in the best case, have a significantly better effect than conventional treatment.
You can find more information about current study projects here under Current Studies. If you are interested, please do not hesitate to contact us directly.
For sponsors & CRO´s
The ISA – Interdisciplinary Study Association GmbH, founded in 2015, brings together the experiences of doctors from dermatology, rheumatology and pediatrics who have been conducting clinical research (Phase Ib-IV) in accordance with the GCP standards in their own practices for more than 10 years.
By bringing together doctors from different disciplines, ISA is able to carry out cross-disciplinary studies.
ISA offers sponsors and CROs the highest quality standards and provides highly qualified, competent study staff.
The ISA network accesses a large patient base. High case numbers are offered through back-ups from individual practices, recruitment of participants in the shortest possible time and monitoring in one place.
ISA’s network parts regularly take part in training courses.
ISA is GCP (Good Clinical Practice), MP-GCP (Medical Products-GCP) and QM (Quality Management) certified.
Our strengths – your advantages
- Carrying out individual and/or interdisciplinary studies.
- Monitoring in a centrally located and state-of-the-art study center.
- Rapid recruitment of suitable subjects in accordance with the inclusion criteria.
- Best test support from recruitment to follow-up.
- Well-founded and cooperative study process.
Studies overview
Current studies
- Study 1 – Information
- Study 2 – Information
- Study 3 – Information
Clinical trials
Clinical study means research on voluntary participants (test subjects) to improve their medical care and for the purpose of further developing medical knowledge. A distinction is made between non-interventional and interventional studies.
In a non-interventional study, no targeted “intervention” takes place. It is limited to observation and documentation.
Interventional (drug) studies are therapy studies in which a specific new treatment method is tested.
In an interventional clinical study, examinations and treatments are carried out on test subjects by a certified investigator according to a specified study protocol and a corresponding study plan. This research may involve medications, medical devices, medical devices, or research into specific behaviors.
Clinical trials compare new treatments with tried-and-tested ones and a placebo that contains no active ingredient. In some clinical studies, medications or medical devices that are already on the market for the same indication are compared with each other (so-called “head-to-head study”).
A new product is examined to determine how it works, whether it works better or worse and how it should be classified in relation to preparations already on the market.
The testing doctors determine the safety data and benefits of the product being tested by carrying out certain examinations and interventions on test subjects and measuring and recording these results. When treating psoriasis, for example, the examining doctor determines whether and how the course of the disease changes after using the new medication and whether the psoriasis can perhaps even be stopped.
Clinical drug studies go through various phases that are defined by German, European and US authorities and are divided into phases I to IV.
Phase I trials are small studies in which a new treatment is used for the first time in humans, namely in healthy volunteers. At this stage, basic pharmacological properties of a new drug are examined to see whether it is even suitable for use in humans.
Phase II trials are slightly larger than Phase I trials. They usually have 100 to 300 participants. In phase II, a drug is tested for the first time in patients who suffer from the disease for which approval is sought. Phase II is about the optimal dosage of a medication. In addition, initial data on effectiveness and safety are being collected.
Phase III studies are large studies that determine whether a drug actually comes onto the market or not. They provide relatively precise information about effectiveness and tolerability. In the vast majority of cases, these are comparative studies in which patients who receive the treatment under study are compared with others who do not receive the treatment.
Phase IV studies take place when a drug is already on the market, i.e. after drug approval. There are different reasons for phase IV studies. It may make sense to specifically examine an already approved drug again in patients with certain properties. In phase IV studies, rare side effects of a drug can also be better assessed because more patients are treated.
(Source: gesundheitsforschung-bmbf.de/de/4835.php)
Participation in studies
Who can take part in a clinical trial?
The selection criteria for the participation of test subjects in a study are set out in the study protocol.
The studies look for either healthy volunteers or test subjects with the disease being investigated.
Why should you take part in a study?
By participating in a clinical trial, you are helping to increase medical knowledge about certain diseases or syndromes. With an improved understanding of an illness, sick people can be cared for more intensively and preventive services can be expanded for people who are not yet sick.
Clinical studies provide the basis for the development and marketing of new drugs, biological products, vaccines and medical devices.
Subjects are examined thoroughly before the start of a study, carefully looked after during the study and provided with the most advanced treatment procedures and medications.
Studies are an investment in a better medical future.
Process of the studies
Who conducts clinical trials?
Clinical trials can be set up and funded by pharmaceutical companies, academic centers or an investigator, self-help groups, health ministries or other health organizations.
Each clinical trial is carried out by an investigator. ISA always uses specialists as investigators. Additional deputy doctors as well as study nurses and a study coordinator complete the ISA team.
Where are clinical trials conducted?
Hospitals, clinical research institutions such as ISA GmbH or doctor’s practices conduct clinical research.
How long does a study take?
The duration of a study depends on what is to be examined. Before inclusion in a study, each test subject is informed about its duration.
Reasons for conducting a clinical trial?
Clinical research is conducted to gain greater medical understanding about the diagnosis, diagnostics, and treatment of a disease, syndrome, or condition. Prevention can be another research topic.
Research includes:
- Evaluation of different interventions, e.g. medications, medical devices, surgical procedures and radiation with the aim of being able to better treat diseases.
- Finding ways to prevent the recurrence of an illness (vaccinations, health care, hygiene, etc.).
- Evaluation of new diagnostic methods in order to be able to detect a disease more quickly.
- Detection of risk factors.
- Increasing quality of life.
The Team
Dr. Margrit Simon
Specialist in dermatology,
Principal Investigator
Antje Schumacher
Dermatologist,
Representative
Principal Investigator
Lankika Samarawickrama
Study Nurse
Fee Marutzky
Study Coordinator,
Study Nurse
Kathrin Wedde
Representative
Study Coordinator,
Study Nurse
Sabine di Muro
Senior Office Manager
Nil Kilisli
Study Nurse
You can reach us
Rankestraße 34
10789 Berlin
Phone: (030) 555 730 810
Fax: (030) 555 730 819
E-Mail: info@isa-research.de
Mon, Tue, Thu, Fri from 9 a.m. to 3 p.m
Wed from 9 a.m. to 6 p.m. and by appointment
* The data protection declarations of the service providers apply.